INITIAL COMMENTS
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This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically methadone, in the treatment of narcotic addiction. This inspection was conducted on February 5-7, 2013 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Lebanon Treatment Center was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection.
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Plan of Correction
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715.6(d) LICENSURE Physician Staffing
(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients
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Observations
Based on the review of administrative documentation, the facility failed to provide at least one hour of physician time a week, on site for, every ten patients for seventeen of the twenty eight weeks reviewed.
The findings include:
Physician time sheets for the months of June, July, August, September, October, November, and December were reviewed on January 6, 2011. Twenty eight weeks were submitted for review and the patient census for those twenty eight weeks were also provided.
During the week of June 9, 2012, the patient census was 231. The facility was required to provide at least 23.1 physician hours. There were 22 physician hours documented.
During the week of June 16, 2012, the patient census was 232. The facility was required to provide at least 23.2 physician hours. There were 17 physician hours documented.
During the week of June 23, 2012, the patient census was 233. The facility was required to provide at least 23.3 physician hours. There were 16 physician hours documented.
During the week of June 30, 2012, the patient census was 237. The facility was required to provide at least 23.7 physician hours. There were 20.1 physician hours documented.
During the week of July 7, 2012, the patient census was 232. The facility was required to provide at least 23.2 physician hours. There were 17 physician hours documented.
During the week of July 14, 2012, the patient census was 234. The facility was required to provide at least 23.4 physician hours. There were 22 physician hours documented.
During the week of July 21, 2012, the patient census was 234. The facility was required to provide at least 23.4 physician hours. There were 19 physician hours documented.
During the week of July 28, 2012, the patient census was 235. The facility was required to provide at least 23.5 physician hours. There were 20.5 physician hours documented.
During the week of August 4, 2012, the patient census was 236. The facility was required to provide at least 23.6 physician hours. There were 22 physician hours documented.
During the week of August 11, 2012, the patient census was 233. The facility was required to provide at least 23.3 physician hours. There were 22.5 physician hours documented.
During the week of August 18, 2012, the patient census was 234. The facility was required to provide at least 23.4 physician hours. There were 22.5 physician hours documented.
During the week of September 8, 2012, the patient census was 245. The facility was required to provide at least 24.5 physician hours. There were 19 physician hours documented.
During the week of September 15, 2012, the patient census was 244. The facility was required to provide at least 24.4 physician hours. There were 17.5 physician hours documented.
During the week of October 20, 2012, the patient census was 242. The facility was required to provide at least 24.2 physician hours. There were 22.5 physician hours documented.
During the week of November 10, 2012, the patient census was 241. The facility was required to provide at least 24.1 physician hours. There were 22.5 physician hours documented.
During the week of November 24, 2012, the patient census was 243. The facility was required to provide at least 24.3 physician hours. There were 22.5 physician hours documented.
During the week of December 1, 2012, the patient census was 244. The facility was required to provide at least 24.4 physician hours. There were 23.5 physician hours documented.
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Plan of Correction
Since our Census Increase, the Lebanon Treatment Center hs been within compliance regarding this requirement. The Director of Nursing will continue to ensure that the weekly Physician Schedule covers the one hour per 10 patient ratio. This is immediate and on-going. |
715.16(f) LICENSURE Take-home priveleges
(f) An exception granted under subsection (d) shall continue only for as long as the temporary disability or exceptional circumstance exists. When a patient is permanently disabled, that case shall be reviewed at least annually to determine whether the need for the exception still exists.
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Observations
Based on the review of patient records, the facility failed to maintain documentation of the need for the continuance of a medical exception for take-home privileges.
Nineteen patient records were reviewed February 5-7, 2013. Three patient records were reviewed for reported medical exceptions.
Patient record # 10 was admitted to the narcotic treatment facility May 2, 2008. At the time of the patient's admission, he had serious medical issues that were to have been addressed surgically in 2008. The patient record documentation indicated multiple cancellations of the reconstructive surgery necessary for him to have some semblance of a normal existence. The only documentation of an exception order for take-home medication was on November 8, 2012 that stated to continue the exception dosing schedule for 30 days. There was no additional documentation that stipulated the initiation of take-home medication for medical reasons.
Patient # 11 was admitted October 26, 2007. The patient received six take home bottles as a medical exception. The documentation for the exception stated the exception was to be discontinued February 2011 but dosing records indicated the patient was continuing to receive take-home medication. When interviewed, staff were unable to explain the reason for the patient to continue to receive take-home medication.
Patient # 12 was admitted November 24, 2007. The patient's record was presented as a medical take home exception. The exception was related to the patient's alleged inability to drive himself to the clinic for dosing. However, in reviewing the documentation the patient continues to abuse illicit substances and work and attend a gym, but not able to come to clinic on a daily basis. There was no documentation supporting the need for ongoing take home privileges.
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Plan of Correction
All existing medical exceptions will be reviewed for appropriateness by Medical Director. Medical exceptions will be approved for a specified duration for which they are assessed as being medically necessary. All ongoing medical exceptions will be reviewed every 60 days by the medical team facilitated by the Medical Director. Director of Nursing will maintain a log of medical exceptions and monitor review dates. Medical Director and Medical Team will receive additional training on these procedures by May 31, 2013. |
715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on the review of patient records, the facility failed to ensure that the physician completed a written dosage change for each patient's dose change in four of four patient records reviewed.
The findings include:
Nineteen patient records were reviewed February 5-7, 2013. Four patient records that were reviewed required documentation of the patient's induction into methadone maintenance.
Patient # 1 was admitted September 4, 2012. The initial dose was to be 25 milligrams with an increase every two days until 50 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse. After 50 milligrams, the dose may be increased 5 milligrams every 5 days until 60 milligrams reached, again at the discretion of the nurse.
Patient # 6 was admitted January 10, 2013. The initial dose was to be 25 milligrams with an increase every two days until 50 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse. After 50 milligrams, the dose may be increased 5 milligrams every 5 days until 60 milligrams reached, again at the discretion of the nurse.
Patient # 8 was admitted September 4, 2012. The initial dose was to be 30 milligrams with an increase every two days until 50 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse. After 50 milligrams, the dose may be increased 5 milligrams every 5 days until 60 milligrams reached, again at the discretion of the nurse.
Patient # 9 was admitted November 6, 2012. The initial dose was to be 30 milligrams with an increase every two days until 50 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse. After 50 milligrams, the dose may be increased 5 milligrams every 5 days until 60 milligrams reached, again at the discretion of the nurse.
The documented practice of structuring dosing orders during the induction phase of treatment is referred to as a standard order. This issue of standing orders was addressed September 4, 2007 when the DEPARTMENT OF HEALTH & HUMAN SERVICES Substance Abuse and Mental Health Services Administration addressed all narcotic treatment facilities, stating in part the following:
"In determining the initial dose for each individual patient, the
physician should consider factors such as body weight, size, other substance use and
abuse, diet, co-occurring disorders (check for prescribed SSRIs, benzodiazepines, HIV
medications, anti-seizure medication, etc.) and medical diseases, genetic factors, and
tolerance. The drug labeling states that "methadone's pharmacokinetic properties,
coupled with high inter-patient variability in its absorption, metabolism, and relative
analgesic potency, necessitate a cautious and highly individualized approach to
prescribing." Even though the Treatment Improvement Protocol (TIP #43) and drug
labeling state that a typical first dose of methadone for a patient actively abusing opioids
is 20 to 30 milligrams, some patients may require a much lower dose. According to 42
CFR 8.12 (h) (3) (ii), "...the initial dose of methadone shall not exceed 30 milligrams
and the total dose for the first day shall not exceed 40 milligrams.. .." (emphasis added).
The initial methadone dose should be appropriate for the individual patient, with the
maximum initial dose being 30 mg. Clearly, a 30-mg dose should not be the initial dose
for all patients.
Of note, there has been a rapid increase in the abuse of the opioid-type pain relieving
medications. Typically, hydrocodone and oxycodone are the drugs of choice, and the
resulting addiction is treated by the OTPs. These are short-acting opioids with a half-life
of 2 to 4 hours. However, methadone has an elimination half-life that can vary from 8 to
59 hours depending on the individual being treated. Thus, methadone induction must be
approached cautiously.
Because methadone overdose deaths have occurred in early treatment due to the drug's
cumulative effects of the first several days, it is also important to be cautious when
adjusting the dose. According to the drug labeling, the peak respiratory depressant
effects of methadone typically occur later and persist longer than its peak analgesic effects, which can contribute to cases of iatrogenic overdose, particularly during
treatment initiation and dose titration. With repeated dosing, "methadone may be
retained in the liver and released slowly, prolonging the duration of action despite low
plasma concentrations." The drug labeling also states that "steady-state concentrations
are not usually attained until 3 to 5 days of dosing," and that doses "will 'hold' for a
longer period of time as tissue stores of methadone accumulate." Therefore, patients
should be closely monitored during the induction phase, and the increase in dose should
be under the close supervision of a physician as stated in 42 CFR 8.12 (h)(4), 'Dosing
and administration decisions shall be made by a program physician familiar with the most
up-to-date product labeling' ."
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Plan of Correction
Upon admission, physician will evaluate patient according to September 4, 2007 Department of Health and Human Services Substance Abuse and Mental Health Services Administration recommendations. Physician will order intial dose not to exceed 40 mgs. Medical director will review and order all dose adjustments. |
715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
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Observations
Based on the review of patient records, the facility failed to complete the annual physical with a re-evaluation by the physician in four of six patient records reviewed.
The findings include:
Nineteen patient records were reviewed February 5-7, 2013. Six patient records were reviewed for the completed annual physical with an re-evaluation by the physician. Four of these patient records failed to include a re-evaluation by the physician, as required.
Patient # 10 was admitted May 2, 2008. The last annual physical in the patient chart at the time of the review was dated January 2011.
Patient # 12 was admitted November 24, 2007. There was no annual physical in the patient record at the time of the review.
Patient # 17 was admitted September 22, 2006. An annual physical was dated September 25, 2012. The documentation by the physician was not readable. Staff reviewed and reported it was documentation about the patient's health status. This is not an evaluation as required.
Patient # 18 was admitted April 13, 2009. An annual physical was dated April 19, 2012. There was no annual re-evaluation as required.
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Plan of Correction
Director of Nursing will generate monthly, computerized report tracking due dates for all patient annual physicals. Utilizing monthly report, nurses will ensure that all patients are scheduled for physicals with physician or physician extender/assistant. All physicals will be reviewed by Medical Director with legible documentation regarding recommendation for continued treatment. |
715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on review of administrative documentation provided during the inspection and staff interviews, the facility failed to submit documentation of unusual incidents to the Department as required.
The findings include:
Administrative documentation that included unusual incident binder was reviewed February 7, 2013. Two of the documented unusual incidents were to have been sent to the Department, but were not.
On April 27, 2012 a patient was involved in a motor vehicle accident (MVA) about 9:30 PM on his way home from classes in Philadelphia. He reported to have fallen asleep. Patient had dosed at the clinic at 11:44 AM earlier in the day. It was a one car crash and patient sustained minor injuries. When patient was questioned by the first responders, the patient acknowledged he was a patient at a methadone clinic. The State Police then charged him as methadone-related DUI (driving under the influence).
On November 12, 2012 it was discovered that form DEA 222 (methadone ordering form) # 114252140, was missing. The nursing area was searched, but it was not located. This has the potential for negative community reaction and community concern.
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Plan of Correction
Director will ensure that all reportable unusual incidents are submitted to the Department within 48 hours. An in-house staff training regarding reportable unusual incidents will be conducted annually. Documentation and proof of submission will be maintained and reviewed weekly. |
715.29(5) LICENSURE Exceptions
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient 's record.
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Observations
Based on a review of patient records and discussion with staff, the facility failed to request an exception to provide phone sessions instead of onsite clinical sessions, as well as maintain documentation of an exception that was to be discontinued February 2011, but continues until today.
The findings include:
Nineteen patient records were reviewed February 5-7, 2013. Three patient records were reviewed for reported medical exceptions.
Patient record # 10 was admitted to the narcotic treatment facility May 2, 2008. At the time of the patient's admission, he has serious medical issues that were to have been addressed surgically in 2008. The patient record documentation identified multiple cancellations of the reconstructive surgery necessary for him to have some semblance of a normal existence. The only documentation of an exception order was on November 8, 2012 that stated to continue the exception dosing schedule for 30 days. The patient continues to receive the take home bottles.
This patient has been having telephonic "counseling sessions" since 2008 and six take home bottles for that length of time.
Patient # 11 was admitted October 26, 2007. This patient receives six take home bottles as a medical exception. The documentation for the exception stated the exception was to be discontinued February 2011. The patient continued to receive the same number of take home bottles without a further order at the time of the inspection. When the nursing supervisor was asked for an explanation or further documentation, she was unable to provide further information.
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Plan of Correction
Clinical Supervisor will complete and submit request(s) for phone sessions as needed. Necessity for all exceptions will be reviewed by medical team every 60 days. Documentation regarding review of necessity of exception(s) will be maintained. |